A multicenter ambispective (retrospective and prospective) non-interventional study of patients with locally advanced or metastatic urothelial carcinoma (adv/mUC) treated with avelumab in France, not impacting the treatment decision made by the treating physician and the medical management of treated patients.
Study Type
OBSERVATIONAL
Enrollment
599
As provided in real world practice
overall survival
time between the first injection of avelumab and the date of death from any cause
Time frame: Avelumab initiation up to 4 years
overall Survival from the start of the chemotherapy used in 1st line
time between the first injection of the chemotherapy used in 1st line and the date of death from any cause.
Time frame: 1st line Chemotherapy start up to 4 years
Progression free survival 1
time between the first injection of avelumab and the date of progression or death from any cause.
Time frame: Avelumab initiation up to 4 years
Progression free survival 2
time between the first injection of avelumab and the date of progression or death from any cause during the 2nd line of treatment post-avelumab.
Time frame: Avelumab initiation up to 4 years
overall response rate
Complete Response or Partial Response as a best response during the avelumab treatment.
Time frame: Avelumab initiation up to 4 years
duration of response
time between the beginning of the response and progression or death from any cause.
Time frame: Beginning of response up to 4 years
duration of treatment
time between the first and last dose of avelumab.
Time frame: Avelumab initiation up to 4 years
Patterns of progression under avelumab
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CHU Charles Nicolle
Rouen, Haute-normandie, France
CHU Nantes
Nantes, Pays de la Loire Region, France
Centre Hospitalier du Pays d AIX
Aix-en-Provence, France
CHU Amiens-Picardie
Amiens, France
Centre Hospitalier Victor Dupouy
Argenteuil, France
Centre Hospitalier Auxerre
Auxerre, France
Institut Sainte Catherine
Avignon, France
Centre Hospitalier de la cote Basque
Bayonne, France
Chru Besancon
Besançon, France
Clinique Tivoli-Ducos
Bordeaux, France
...and 71 more locations
Metastatic sites and type of progression (new lesion(s)/progression of known lesion(s)).
Time frame: Avelumab initiation up to 4 years
Adverse events (AEs) reporting
Adverse events (AEs) of any type, grade 3-4 AEs, AEs leading to interruption or discontinuation, AEs leading to death.
Time frame: Avelumab initiation up to 4 years
Premedications (acetaminophen and antihistamine)
Proportion of patients who received a premedication at each injection of avelumab. Median number of cycles with premedication.
Time frame: Avelumab initiation up to 4 years
Patient reported outcome
Evolution of PROs NCCN/FACT FBlSI-18 and EQ-5D-5L scores during avelumab treatment.
Time frame: Initiation of avelumab, 6 weeks, 3 months, and every three months for up to 2 years
Overall response rate on subsequent treatments
Complete Response or Partial Response as a best response during the subsequent treatments
Time frame: Discontinuation of avelumab up to 4 years
Duration of subsequent treatments
time between the first and last dose of subsequent treatment
Time frame: Discontinuation of avelumab up to 4 years
Progression free survival on subsequent treatments
time between the first dose of subsequent treatment and the date of progression or death from any cause
Time frame: Discontinuation of avelumab up to 4 years
Overall survival on subsequent treatments
time between the first dose of subsequent treatment and the date of death from any cause
Time frame: Discontinuation of avelumab up to 4 years